New version of the guidance document Voluntary Harmonisation Procedure for clinical trials

03 May 2013,
Updated 09 July 2013

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April saw the release of version 3 of the Voluntary Harmonisation Procedure (VHP), a voluntary procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries.

Version 3 includes the following changes:

Introduction of a reference national competent authority (NCA).

Introduction of a second round if the sponsor wants to include additional countries in the trial authorised in a VHP.

Procedural steps to address the fulfilment of conditions established in VHP.

The VHP was developed and launched by the Clinical Trial Facilitating Group (CTFG). The CTFG was formed in 2004 by the Heads of Medicines Agencies (HMA), one of the purposes being to obtain a more uniform interpretation of the EU regulatory requirements. The VHP was launched as a pilot project in February 2009.

Applications for assessment under the VHP should be submitted to the VHP secretariat. You can read more about the procedure in the above guidelines.

The VHP assessment is conducted and coordinated between the national competent authorities (medicines agencies) of the countries in which the trial is to take place following which the application is submitted to the countries involved.

It is an offer through which sponsors can obtain a harmonised assessment of an application. The actual trial must still be authorised at national level, and it is therefore not a centralised authorisation.

Provided that the VHP assessment reaches consensus, the scientific content of the application must not be changed when submitted to the national competent authorities. However, it may be adapted to meet national requirements.